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PubMedDate not supplied

Effects of reorganization on laboratory quality: preliminary findings and lessons learned.

Reorganization and downsizing are common challenges for managers. This case study describes the implementation of a major restructuring of a clinical laboratory within a large, integrated medical-delivery organization. Economic trends prompted us to evaluate the effects of a major laboratory reorganization, with a significant shift from clinical laboratory scientists to lower waged, nonlicensed technical staff, on the analytic quality and other indicators of laboratory performance. Although a laboratory reorganization may be implemented slowly, this reorganization effort was completed quickly. Data were collected during both the pre- and post-reorganization period. Postimplementation performance indicators show no reductions in analytic quality. Effectively dealing with the human side of significant change appears to be the biggest challenge for managers, both in the short term and well after the reorganization. These results and qualitative information and insights might be of value to laboratory management contemplating a laboratory reorganization.

California↗
PubMed2003

Investigation of biological risk in mycobacteriology laboratories: a multicentre study.

SETTING: Microbiology laboratories constitute a special working environment that may pose a risk of infectious disease to persons in or near them. OBJECTIVE: To assess whether clinical mycobacteriology laboratories in Spanish hospitals comply with occupational health and safety guidelines, and if laboratory workers are protected against the risk of exposure to biological agents in the workplace. DESIGN: A transversal epidemiological study was carried out in 26 hospitals from October to December 2000 by means of a standardised survey questionnaire to evaluate the workers, workload, training and information and safety practices in mycobacteria laboratories. RESULTS: Less than half of employees receive periodic information on the health hazards involved in their work. More than a third of the workers in mycobacteriology laboratories stated that the laboratories lack effective air filtering systems and more than half stated that negative pressurisation was not maintained in the work area. Biosafety masks are used by little more than half of the workers. The most frequently used Biological Safety Cabinets are Class IIB. CONCLUSION: Our findings demonstrate that clinical microbiology laboratories in Spanish hospitals comply poorly with the prevention measures outlined in the applicable directives and regulations.

Adult↗
PubMedDate not supplied

Hospital clinical laboratories are in a constant state of change.

In response to the accelerating changes in the health-care field, there has been a great deal of attention devoted to creating flexible designs and furnishings in hospital-based clinical laboratories. Even so, the hypothesis that hospital laboratories require a high degree of flexibility has been essentially untested. The aim of this study is to confirm or negate this need for flexible designs and furnishings as well as provide guidance for addressing flexibility in future hospital laboratory constructions and renovations. To explore the nature and rate of change in clinical laboratories, a multi-methodological approach employing both survey research and case study research was used to triangulate conclusions. Findings are organized into three areas: specific activities, technological processes, and the physical environment. The physical environment is further divided into three physical layers: infrastructure systems, space plan, and contents in the laboratory. This research supports the premise of planning and designing clinical laboratory environments that are flexible and versatile to support multiple laboratory applications. The goal of this study is to contribute to a body of knowledge that will help reduce the recurring problem of obsolescence in health-care buildings by understanding the relationship between activities, the technological processes, and the physical environment.

Automation↗
PubMed2005

[The ideal form of laboratory information management].

In a clinical laboratory, not many staff can point out the problems of laboratory information management. Although the clinical laboratory introduced information systems in early stage, no organization supplies specialists to this field. Much knowledge is hidden in the clinical laboratory data, which can be discovered by data-mining technology. We can contribute to medical development with this technology. Moreover, the cost of routine work and research work may also be mitigated. However, data-mining technology including structurally recorded data and diversified analytic systems are required to build such capability. The laboratory information management division should make sufficient use of the formal information with non-fixed data base searching. This section should become an important section in the hospital by supplying advanced knowledge discovery and strategic decision-making. In this paper, we discuss the necessity of the information education in the clinical laboratory field and describe the importance of information management in a clinical laboratory.

Clinical Laboratory Information Systems↗
PubMed2006

Laboratory use in Ghana: physician perception and practice.

Clinical diagnosis of infectious diseases in Africa has been associated with increased misdiagnosis and mortality, but when laboratory testing is available, it remains underused. We retrospectively compared infectious diagnoses, test results, anti-microbial use, and patient cost with laboratory and physician surveys at a teaching hospital in Ghana to evaluate the potential barriers to laboratory use and financial impact for patients. Laboratory capacity was high, but physician survey results and objective data indicated a reliance on clinical judgment and empirical therapy. For the study period, 9-15% of malaria diagnoses, 34-43% of urinary tract infections (UTIs), and 62% of meningitis cases were supported by abnormal laboratory results. For the same period, 0.82-2.09 units of antibiotics were consumed per patient day, and patient cost for antibiotics was 4.8-21.6 times that of laboratory testing. Physician perception regarding the value of diagnostic testing is potentially a major barrier to laboratory use, resulting in empiricism, disproportionate anti-microbial administration, and cost to patients.

Anti-Infective Agents↗
PubMed1990

Physician performance of laboratory tests in self-service facilities. Residents' perceptions and performance.

Primary care physicians perform simple laboratory tests in clinical practice, frequently with little formal training. To determine the frequency of tests that are performed and evaluate house officer laboratory skills, we surveyed house officer attitudes and tested their ability to perform four common laboratory tests. We received 193 responses from 254 house officers at one university teaching hospital. While most perceived the need to use ward laboratories (ie, self-service laboratories located on patient care wards), 67% used them infrequently. Barriers included poor laboratory condition, inadequate time, accuracy, and infectious exposure concerns. Twenty-four percent felt they did not know or were unsure if they knew how to perform simple tests. Forty-seven house officers completed the practical examination. Most accurately reported a spun hematocrit and correctly identified white blood cell findings on a blood smear. Only 50% counted 100 cells. Urinary dipstick interpretation was generally acceptable but the microscopic examination was less accurate. Twenty-three percent failed to identify gram-negative rods on a slide with both gram-positive cocci and gram-negative rods. If physicians are to perform selected laboratory tests, these data suggest, at least in one institution, more formal training, practice, and evaluation are necessary to ensure their performance with adequate proficiency.

Attitude of Health Personnel↗
PubMed1988

Multiprogram characterization of laboratory bias, precision, and total error. Proposal for improved assessment with shared external and expanded internal (regional) quality control pools.

We establish that, for the analytes aspartate aminotransferase, glucose, phosphorus, and potassium, there is significant correlation between laboratory performance as determined by College of American Pathologists-sponsored external (Surveys) and expanded internal (regional) quality control (Quality Assurance Service) programs. However, relatively low parametric and nonparametric correlation coefficients and significant departure of linear regression slopes from unity reflect major differences in the calculated parameters of absolute bias, precision, and total error obtained through internal and external quality control. Significantly better performance in both Surveys and the Quality Assurance Service was documented for laboratories participating in the College of American Pathologists Laboratory Accreditation Program. Multiple descriptors of laboratory quality, as indicated here, are superior in describing laboratory performance to proficiency testing alone. As a bridge between external and internal quality control, shared pools of quality control materials are described for use as unknown Survey challenges and subsequent distribution for regional quality control. Such programs, which can be configured to serve thousands of laboratories, could offer cost savings, better quality assurance, and improved characterization of laboratory performance by minimizing interprogram differences in control matrix and method classification and providing greater reliability of target values.

Academies and Institutes↗
PubMed1978

The interdisciplinary approach to laboratory medicine.

The clinical laboratory is a melting pot of diverse scientific experiences, perspectives, and approaches, all directed to the solution of particular medical problems. Integration of separate disciplines and areas of expertise is involved at serveral different levels of laboratory medicine. At the outset, one sees that any one area of the laboratory must depend upon all other laboratory areas for the proper interpretation of its data. Stated another way, all laboratory disciplines are involved in the integrated functioning of each individual area. Examination of the origin of analytical concepts fundamental to procedures and instruments utilized in the clinical laboratory leads one to realize that all areas of science contribute to laboratory medicine.

Clinical Laboratory Techniques↗
PubMed1984

Clinical laboratory responses to reduced funding.

Economic forces have been set in motion by recent legislation that are very likely to reduce available funds for clinical laboratories in hospitals. The effect of these impending developments on patient care is of great concern to clinicians and laboratorians. There is a range of available coping strategies that have broadly different consequences for the traditional role of the laboratory in patient care. The first seeks to preserve existing test ordering and reporting behavior by employment of straight cost cutting in the laboratory. The second calls for consciously determined selective degradation in laboratory services and functions. The third depends on decreased utilization of the laboratory achieved by indirect or direct intervention by laboratorians on the free ordering practices of clinicians. The fourth involves reorganization of the laboratory with new institutional relationships that variably affect laboratory function.

Clinical Laboratory Techniques↗
PubMed1993

[The physician executive and laboratory tests].

Sera Central Hospital was founded in 1953 as Sera District Medical Center under the auspices of the neighboring five towns. At that time, the hospital had 3 doctors, 10 nurses, and 20 beds. But now in 1992, we have 12 doctors, 53 nurses and 110 beds. The present medical specialists are physician (4), surgeon (2), orthopedist (3), pediatrician (1), clinical laboratory physician (1), and dentist (1). Although the yearly income and expenditures were well balanced until 1989, thereafter the income began to decrease insidiously and expenditures began to increase year by year. In this symposium titled "Suggestions for Clinical Laboratory Medicine by Experienced Hospital Directors," I must refer to the issue of "Clinical Laboratory Medicine Administrator's Standpoint". Recently, the unaccustomed phrase "Physician Executive" is occasionally heard as the details of medical care become more numerous and more intricate and economic efficiency is strictly persued. From this perspective, the clinical laboratory physician is responsible for managing the laboratory department with well disciplined knowledge and technique. Therefore, training as "Physician Executive" has developed naturally within the field of Clinical Laboratory Medicine. So, I cannot help coming to the conclusion that the management of a hospital, as a matter of course, will be entrusted to a doctor including clinical laboratory physician who can do his best for the citizens, for the patients, and ultimately for ourselves.

Clinical Laboratory Techniques↗
PubMed1998

Proficiency testing in laboratory medicine: uses and limitations.

OBJECTIVE: To provide a critical review of recently published literature on the effectiveness, uses, and limitations of proficiency testing (PT) as a mechanism for laboratory improvement, and to explore ways to improve the PT process. DATA SOURCE: All publications identified by a MEDLINE search of the literature dating back to 1987 on the subject of "proficiency testing" in laboratory medicine, as well as selected references cited in recent review articles. STUDY SELECTION: No specific selection criteria were used for inclusion of publications identified by the MEDLINE database as long as they dealt with PT as a mechanism of medical laboratory improvement or a measure of laboratory performance. DATA EXTRACTION: Abstractions of data were made depending on relevance of the data. DATA SYNTHESIS: Proficiency testing data are an indicator, but not a measure, of laboratory performance. Limitations of current PT practices are incomplete assessment of the total testing process, PT materials being treated differently than those from patients, PT performance criteria, and "matrix effect." Proficiency testing performance has been related to length of PT experience, test environment and volume, institutional size, laboratory and analyst workload, difficulty of PT materials, performing quality control, testing methodology, and degree of automation. CONCLUSIONS: Proficiency testing has a well-established role as both a laboratory improvement and an educational tool. There are, however, several practical and design limitations even for the best-administered PT programs. Suggestions to improve the PT process include increased reliance on PT results in combination with other quality indicators (such as performance in regional surveys), occasional use of "blind" PT, introduction of biological materials to PT participants, electronic grading and reporting of PT results, and introduction of challenging PT materials to fulfill the educational role of PT.

Clinical Competence↗
PubMed1997

Quality management in the andrology laboratory.

Quality control in an andrology laboratory deals with multiple variables and complexities well beyond those in other laboratories. Therefore one of the most common reactions to demands for quality management in andrology is that 'quality' in assisted reproduction techniques (ARTs), especially in andrology, is not measurable. In spite of this reaction the following path must be adhered to in order to guarantee and improve quality in the andrology laboratory: after the term 'quality' is defined, criteria for quality must be set up and followed according to certain quality guidelines, which may originate from the literature or may be derived from the results and experiences within each laboratory. The implementation of working procedures according to the guidelines covers the activities in an andrology laboratory. The effectiveness of some of them is, however, evaluated differently and therefore they are discussed controversially. High-quality laboratory work is essential but what is actually done with the data received is of equal importance. It is the interface between quality control and quality assurance. The evaluation of results discovers the causes of problems, finds a way of correcting them, and anticipates future occurrences. A quality control programme must contain the handling of laboratory equipment as well as the preparation of media and, at first, the semen analysis which is performed either manually or automatically according to WHO criteria. Furthermore, it includes all common techniques of sperm preparation and, in addition, migration and survival tests for the determination of sperm function.

Clinical Laboratory Techniques↗
PubMed2006

Laboratory abnormalities in ambulatory patients with myotonic dystrophy type 1.

BACKGROUND: Myotonic dystrophy type 1 (DM1) is the most prevalent form of adult muscular dystrophy worldwide. Although well known for the classic manifestations of myotonia, weakness, and early cataracts, it has broad effects on multiple organ systems. OBJECTIVE: To analyze and compile the laboratory abnormalities of 126 adult patients with DM1. DESIGN: Laboratory data obtained before treatment were compiled and include values for 45 different laboratory tests and 2860 total studies. SETTING: University hospital. PATIENTS: One hundred twenty-six medically healthy, mild to moderately affected, ambulatory patients with DM1 and good venous access enrolled in one of 12 major DM1 clinical trials at a university hospital from 1975 to 2005. RESULTS: Of the 2860 laboratory studies, results for 470 (16.4%) were outside their reference ranges. Of the 45 types of laboratory tests studied, 41 demonstrated abnormal findings. The relative frequency of an abnormally elevated laboratory value was greater than 50% in several tests, including levels of hemoglobin A(1c), follicle-stimulating hormone, luteinizing hormone in men, and gamma-glutamyltransferase and creatine kinase in women. In addition, levels of lactate dehydrogenase in men and hemoglobin in women were abnormally high or low in more than 50% of the test results evaluated. CONCLUSION: There is a high frequency of abnormal laboratory values in DM1 that may form a basis for early screening and monitoring and provide insight into the spectrum of tissues involved in this disease.

Adult↗
PubMed1996

Inability of community-based laboratories to identify pathological casts in urine samples.

OBJECTIVE: To determine the accuracy of microscopic examination of urine from patients with known renal disease, performed by community-based laboratories. DESIGN: Twenty-six urine specimens from 7 children with Alport syndrome, lupus nephritis, and IgA nephropathy were simultaneously submitted to 4 investigative sites: 2 community-based medical laboratories (laboratories A and B), and the offices of 2 nephrologists (nephrologists C and D). Participants A, B, and C were unaware of the nature of this investigation and blinded to the diagnosis associated with each specimen. RESULTS: Twenty-six specimens from 7 children were analyzed. Pathological casts were identified in the 26 submitted specimens in the following order: 1 (4%) by laboratory A, 2 (8%) by laboratory B, 20 (77%) by nephrologist C, and 26 (100%) by nephrologist D. Four-way and 3-way (A, B, C) comparisons using the chi 2 test are significant at the P < .001 level. CONCLUSIONS: The 2 community-based medical laboratories participating in this study did not accurately identify pathological casts in urine specimens routinely submitted to them. In addition to raising quality assurance issues, these misleading reports may result in inaccurate diagnosis and unnecessary laboratory and diagnostic investigations.

Diagnostic Errors↗
PubMed1987

How will changes in physician payment by Medicare influence laboratory testing?

In-office laboratory testing offers physicians an opportunity to increase their incomes through the potential profit available from technical services. This financial incentive for in-office testing has been altered by Medicare limits on physician payment, legislative changes in physicians' ability to bill Medicare for laboratory tests, and technological advances in office laboratory equipment. While restrictions on payment may make laboratory testing relatively less profitable than other technical services offered in the physician's office, in-office laboratory testing still offers potential financial benefit to physicians, particularly if they can influence the demand for tests. Economic theory suggests that physicians may be able to increase the demand for their services, including laboratory testing, but empirical data are not conclusive. As Medicare and other third-party payers consider fundamental reform in physician payment, the effect of different payment schemes on physicians' use of laboratory tests may have important consequences for physicians' income, the quality of care, patients' access to care, and the cost of the Medicare program.

Costs and Cost Analysis↗
PubMed1994

Laboratory monitoring of warfarin therapy in Utah.

Accurate laboratory monitoring of oral anticoagulation has been emphasized as an important factor in providing safe and effective therapy for patients with thromboembolism. However, recent reports indicate that coagulation laboratories may not be providing optimal clinical information to clinicians who treat these patients. We surveyed all hospital coagulation laboratories in Utah to determine their format for reporting prothrombin time results in patients receiving oral anticoagulants. We found that less than 50% of laboratories used the reliable reporting format, i.e., the International Normalized Ratio (INR), and that many of the laboratories using the INR format may be reporting incorrect values. Our survey also found a significant lack of interest by physicians in requesting that their laboratories adopt reliable reporting methods. These results indicate a substantial lack of understanding by laboratories and clinicians of the importance of using reliable methods to monitor oral anticoagulation. Significant educational efforts will be required to correct this problem.

Drug Monitoring↗
PubMed1983

What is the appropriate "dress code" for the cardiac catheterization laboratory?

In order to determine the effect of the manner of dress by personnel and observers on cardiac catheterization-related infections, a retrospective survey was undertaken of 107,203 catheterization procedures done during the calendar year prior to this survey. An analysis of 55,976 cutdowns and 53,578 percutaneous procedures was performed (some subjects had both procedures performed). A total of 379 infections in 109,554 entrance sites were reported for an overall incidence of infection of 0.35%. There were 33 infections at the percutaneous site (incidence = 0.06%) and 346 at the cutdown site (incidence = 0.62%). The manner of dress of personnel not involved with catheter manipulation and of the observers had no relationship to the incidence of infection when the percutaneous technique was used. When cutdowns were performed, there was a lower incidence of infection in those laboratories where all personnel and observers were required to wear a mask, cap, and gown (17,311 cutdowns, 83 infections, 0.48% infection rate) than in those laboratories where none of these was required (15,170 cutdowns, 109 infections, 0.72% infection rate) (P less than 0.025). Laboratories which did 150 or less cutdowns/year had more infections than those laboratories performing more than 150/year (P less than 0.0001). Our data suggest that the risk of infection from cardiac catheterization is more closely correlated with the volume of studies done in the laboratory than in the manner of dress of the laboratory personnel and visitors in the laboratory. However, the wearing of full "sanitary clothing" will help decrease the infection rate in cutdowns.

Cardiac Catheterization↗
PubMed1991

Cardiac catheterization laboratories: should every hospital have one?

It is obvious that times have changed. Cardiac catheterization laboratories are everywhere. The concerns that must be addressed continually are: 1. Patient safety and quality of patient care. 2. Access to emergency hospitalization. 3. The overseeing of these laboratories. 4. Physician conflict of interest. 5. Need for the laboratory in the region In order to add a new cardiac catheterization laboratory to any region, patient need must be documented. Patient need is the only justification for the development of a new laboratory. I fail to understand how the continuing development of new laboratories will decrease costs, and am concerned that more catheterization laboratories will mean more studies of patients with borderline indications for the procedure.

Cardiac Catheterization↗